A
recent publication by a conservative watchdog group has rekindled media
interest in a controversial anti-virus vaccine and sent Big Pharma and
federal health agency officials into damage control mode.

In
a 25-page special report released June 30, Judicial
Watch -- a Washington DC-based nonprofit organization that promotes
“transparency and accountability in government” – presents evidence
based on government documents that in the two years since being licensed
by the Food and
Drug Administration, Merck & Co’s
Gardasil, heavily promoted as a
safe and effective vaccine against cervical cancer, has been connected
with nearly 9,000 “adverse events,” including the deaths of 18 – perhaps
20 – girls and young women.

In
addition, there were 140 “serious” events reported (27 categorized as
“life-threatening”), with 10 spontaneous abortions and six cases of
Guillain-Barre Syndrome – all since January 2008.

Guillain-Barre
Syndrome (GBS) is a rare, potentially devastating autoimmune disorder
that attacks the peripheral nervous system and can lead to paralysis
and, occasionally, death. There is no known cure or cause, but a fact
sheet from the National Institute of Health says it’s sometimes
triggered by surgery or vaccinations. Judicial Watch uncovered a total
of 38 cases of GBS have been filed with the FDA since June 2006 (six
since January) among girls who had received at least one dose of the
three-dose vaccine.

The
records indicate 10 deaths since last September, bringing the total
number of Gardasil-connected death reports in the United States to at
least 18 – four of these were from blood clots, nine from unknown or
unidentifiable causes.

The
fatalities include:

A 20-year-old woman with no medical history reported, who was vaccinated
April 1, 2008, with Gardasil and died four days later, seeking medical
attention. An autopsy was performed which ruled out suicide or anything
suspicious. The cause of death is currently unknown. [VAERS ID 310262-1
(D)]

A 12-year-old girl with no reported medical problems, who died in
her sleep of known causes on Oct. 6, 2007, three weeks after receiving
a Gardasil shot. [VAERS ID: 297528-1 (D)]

An 11-year-old girl, vaccinated in May 2007 with a first dose of
Gardasil, who died three days later after going to an emergency
room. A physician at the hospital said “death was due to an anaphylactic
[severe allergic] reaction to Gardasil.”[VAERS ID 280163-1 (D)]

Because
adverse reactions to medication tend to be underreported, Judicial Watch
believes the actual number is likely to be higher.

“I
think we’ve uncovered a lot of disturbing things about Gardasil,” said
Judicial Watch president Tom Fitton. “All we’re asking for is further
investigation of its safety. We’re not convinced they’re taking these
reports seriously.”

Gardasil
is the first vaccine on the market that targets the four strains of
sexually transmitted human papillomavirus (HPV) believed to account
for most cases of cervical cancer and genital
warts infections.

HPV
is not contagious in the way tuberculosis or measles or the common cold
is. You don’t become HPV-infected by being in a crowd or sitting near
someone, but through skin-to-skin contact. There are over 100
strains of HPV, 30 of which are sexually transmitted – and of these
30, 15 can cause cervical lesions and other abnormalities that may develop
into cervical cancer, while about 12 can cause genital warts. Two of
the strains targeted by Gardasil (HPV 16 and 18) are believed responsible
for 70 percent of the cancer cases, the other two (HPV 6 and 11) cause
90 percent of the genital warts infections.

The
FDA approved Gardasil on June 8, 2006, for girls and women ages nine
to 26. Less than a month later the Centers for Disease Control and Prevention’s
Advisory Committee on Immunization Practices (ACIP) recommended vaccination
for all girls, ages 11 to 12. The committee’s
first report on Gardasil was published the following March.

Gardasil
was fast-tracked and received FDA approval before testing was complete
and its final safety evaluation trials won’t be concluded until Sept.
2009. Despite this, the drug is being aggressively mass-marketed on
TV and at the movies in ads pitched to young girls, including preteens,
and state legislators were heavily lobbied to make the drug mandatory
for school girls ages 11 up. Sold worldwide, Merck reports over 16 million
doses of the vaccine have been distributed in the U.S. , and eight million
women and girls have received at least one shot of the three-dose regimen.

The
special
report – its complete title is Examining the FDA’s HPV Vaccine
Records: Detailing the Approval Process, Side-Effects, Safety Concerns
and Marketing Practices of a Large-Scale Public Health Experiment
-- continues work Judicial Watch began in 2007 when it published two
analyses (the first in May of that year, the second in Oct.) of Gardasil-related
documents it had received in sets from the FDA, after making requests
through the Freedom of Information Act.

As
in its earlier reports, the group raises serious questions about the
vaccine’s effectiveness, safety, long-range effects and overall costs
-- which are astronomical. At $120 a shot ($360 for the requisite three-doses),
Gardasil is the most expensive vaccine on the market.

The
VAERS Reports

Using
FOIA, Judicial Watch obtained thousands of pages from the FDA, including
8,864 reports filed by doctors, nurses, parents and others with the
Vaccine Adverse Events Reporting
System [VAERS] – a database shared by the CDC and FDA -- detailing
reactions experienced by girls and women after receiving at least one
shot of the vaccine.

Besides
the deaths, the VAERS reports reveal a gamut of reactions – from trivial
to terrifying -- including vomiting, dizziness, seizures, paralysis
and Guillain-Barre Syndrome, swelling at the injection site and in lymph
nodes in the neck and groin, fevers, hives, shortness of breath, nausea
and flu-like symptoms.

There
were reports of a sudden appearance of blisters on a 20-year-old's upper
arms and back and ano-genital warts on a 12-year-old. A 15-year-old
reported blisters that appeared in her vaginal area within two days
of receiving the vaccine and spread to her upper body and behind her
ears and knees. These lasted five to seven days, then developed scabs.

Judicial
Watch’s use and dissemination of VAERS reports have drawn criticism
from the FDA, the CDC, Merck and other advocates of the vaccine, in
part because anyone can file a VAERS report -- physicians, nurses, family
members and patients -- so the accounts tend to be dismissed as “anecdotal”
and lacking-in-evidence. More important, they don’t prove the vaccine
caused the event.

In
the wake of the Judicial Watch report, Merck issued a
press statement downplaying the findings.

The
mega-drug company claimed to have “analyzed the adverse events reported
for Gardasil … and based on the data available to Merck, believes that
no safety issue related to the vaccine has been identified. … An adverse
experience report describes an event that occurred after vaccination
and does not necessarily mean that the vaccine caused or contributed
to the event. The vast majority of adverse events that have been reported
to Merck are non-serious and the most common include dizziness and syncope
(fainting).”

In
a similar vein, FDA spokeswoman Kelly Riley told the Sydney Morning
Herald, an Australian newspaper, that there was nothing in the VAERS
reports to cause a review of the usefulness of the vaccine. “These adverse
reaction reports have not been analyzed. If there’s a death after someone
received a vaccine, and long after they had a car crash, a bee sting
… these would be filled out. It does not mean Gardasil caused it.”

The
FDA and CDC said that safety data reviewed in approving Gardasil showed
only mild side effects, like pain at the injection site or fainting.

But
Tegan Millspaw, the report’s lead researcher and principal author, says
these critics are missing the point.

“Judicial
Watch was not and is not interested in proving causality,” she writes.
”Only science can do that. And that is why we asked for more investigation
of the VAERS reports to ensure there was no causality between Gardasil
and the serious reported adverse reactions”

There
were 18 deaths, she points out – and of those, 11 occurred less than
a week after the girl had received the vaccine, seven in less than
two days.

“Perhaps
all these deaths are simply coincidence, but given the unknowns about
Gardasil and its overall safety, it is far too important an issue to
simply ignore,” Millspaw states.

Making
Bad Symptoms Worse

Attracting
less attention from the media are the cases of groin and genital warts
– 78 VAERS-reported cases -- which weren’t supposed to happen considering
that Gardasil is a vaccine against the two strains of HPV that cause
90 percent of such outbreaks. But Gardasil is not a cure, it is a preventative
medication – and in some instances it seems to have triggered outbreaks
or made existing conditions worse, for there are reports of warts suddenly
appearing after vaccination on the face, hands, feet and chest.

“Not
only will Gardasil not cure pre-existing HPV, it can also make symptoms
worse,” warns Millspaw in the report. “Women who already have the virus
without knowing it could suffer massive outbreaks of genital warts or
abnormal precancerous lesions, both of which require extensive treatment.”

“The
outcomes that can result from pre-exposure are disconcerting and deserve
far more attention.”

Contacted
by telephone, Millspaw told NewsWithViews of her concern that Merck
did not screen women prior to vaccination for possible HPV exposure
or infection.

“The
reason they target very young girls is it’s easier to assume they don’t
have the viruses – but the women are not screened to see if they’ve
been exposed. The FDA allows that, which I find very disturbing.”

Asked
whether the drug could cause sterility, Millspaw told NewsWithViews
there’s “no indication” of this – “but they’re now vaccinating very
young girls, so it will be years before long-term effects are known.
They haven’t done enough tests to know at this point.”

Millspaw
brought up another long-range possibility. “A lot of scientists are
worried that preventing these four strains may just cause other HPV
viruses to take their place,” she said. “That could be serious, particularly
because while the vaccine protects against two main forms of cervical
cancer the other [13] strains are usually more severe.”

“Given
all the questions about Gardasil, the best public health policy would
be to re-evaluate its safety and to prohibit its distribution to minors,”
said Tom Fitton in a press
release. “In the least, governments should rethink any efforts to
mandate or promote this vaccine for children.”

Backlash

Fitton
was referring particularly to the action that sparked the most controversy
about the vaccine and unleashed a furious backlash against it: Merck’s
aggressive lobbying aimed at state legislatures.

The
company began marketing the drug even before the FDA gave the green
light. Not by name – that would be illegal -- but through a sophisticated,
high-pressure public relations campaign using TV and Internet ads designed
to frighten young girls about cervical cancer and HPV, so that they
would accept – and demand – the drug once it became available.

But
Merck was not content merely to advertise the vaccine and make it accessible
to those who wanted it; as soon as it got the high-sign from the FDA
it funded a huge lobbying effort to persuade state lawmakers to mandate
Gardasil vaccination of young girls, including preteens, as a condition
for attending public or private school.

The
campaign has been fairly successful. To date: 41 states have introduced
legislation to require, fund or educate the public about the HPV vaccine
and 17 enacted legislation. Three considered making vaccination mandatory.

It
was too much. Parents and consumer advocates from all points across
the political spectrum were outraged, and in Feb. 2007 Merck announced
it was dropping its lobbying campaign – though its TV advertising continues.
But the lobbying was so intense, many former supporters were inspired
to take a closer look at Merck and to question its motives for mass-marketing
a drug before it’s been fully tested and evaluated for safety and efficacy.

A
‘Wonder Drug’ for Merck?

For
instance, last July Judith Siers-Poisson, editor of PR Watch, authored
a devastating four-part series for CounterPunch, a leftist biweekly
newsletter, titled “The Politics
and PR of Cervical Cancer,” in which she took a hard look at HPV
and Gardasil – “the facts, the hype, and what Merck stands to gain,
the marketing campaigns … and the media’s lack of attention to concerns
about the rush to mandate vaccination…”

“Guardasil
is being touted as a “wonder drug” for women. Might it also be a wonder
drug for Merck?” Siers-Poisson asked then answered:

“In
the world of drugs, vaccines for use by the whole population are close
to corporate nirvana since they ensure a mass market for prevention
instead of having to wait to identify the smaller number of people who
actually develop a particular disease. In addition, mandating vaccination
helps ensure a mass market and gets the government involved in what
would otherwise be left to market forces.”

The
drug could likely go far in replenishing the pockets of the firm as
it recovers from the Vioxx recall, in which Merck’s pain medication
was held to be responsible for 27,000 heart attacks and sudden cardiac
deaths. Analysts estimate that the Vioxx recall decreased Merck’s stock
value, and could cost Merck up to $20 billion in legal settlements.

At
$360 for the three-shot regimen, Gardasil is the most expensive vaccine
the FDA has ever approved. A measles-mumps-rubella combo costs $42.85.
The New
York Times estimates that making the vaccine mandatory would double
the cost of existing vaccine programs. And John Schiller, a senior investigator
for the National Institute, told the Times “This vaccine will be more
expensive than all childhood vaccines put together.”

But
whether paid for by insurance, tax dollars, or individual parents –
at $360 a patient Merck is guaranteed billions of dollars.

It’s
already paying off. Even without Gardasil being mandated, the incessant
campaign has persuaded millions of young women to be vaccinated – and
netted Merck $1.5 billion in sales revenue in 2007, according to the
Securities and Exchange Commission.

How
Serious a Threat?

But
how serious a threat is the disease which is already costing millions
of dollars to vaccinate against?

Cervical
cancer is a major killer of women in non-industrial nations – as it
once was in this country. Worldwide it affects 470,000 women and kills
233,000 each year. This is not the case in the United States thanks
to widespread Pap screening. This is a medical screening test involving
the examination of cells taken from the cervix to detect pre-malignant
and malignant cervical cancer cells. It is named after its inventor,
Dr. George Papanicolaou, who developed it over 60 years ago.

As
a result of routine Pap tests and early, follow-up treatment when necessary,
the deaths from cervical cancer plummeted 74 percent between 1955 and
1992, according to the American Cancer Society, and that rate continues
downward by about four percent a year.

Today
in the United States cervical cancer is so rare that it is not on the
National Cancer Institute’s list
of 13 most common cancers. To qualify as a common cancer, the estimated
annual incidence for 2008 had to be 35,000 cases or more.

Nor
is it among the top 10 deadliest diseases for women, which are heart
disease and stroke, followed by lung cancer (third place, with 71,030
deaths), breast cancer (6th, with 40,480 deaths) and colon cancer (10th
with 25,700 deaths), according to the American Cancer Society.

The
American Cancer Society estimates that in 2008, about 11,070 women in
the United States will be diagnosed with invasive cervical cancer in
the United States and 3,870 women will die from it. The tragedy behind
those deaths is that they could likely have been prevented had the women
received regular Pap tests and treatment.

Millspaw
concludes: “With these statistics in mind, one must ask whether Gardasil
vaccination is absolutely necessary, especially for children. At this
point in time, we do not know if it will prevent cancer, or whether
it will have unforeseen consequences. The American public must ask themselves
if Gardasil is really worth the risk. Fast-tracking drugs and vaccines
before their safety has been fully evaluated is unethical and dangerous,
and until more tests have been completed on Gardasil no vaccination
mandates should be established.”

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Below
is a list from the special report summarizing objections to the vaccine

Gardasil has not been tested thoroughly enough to know whether it
will be safe or effective in the long term.

Even if it is shown that the Gardasil vaccine is effective, it is
still unknown how long the vaccine lasts or if there will be a need
for booster shots.

Regardless of its potential to help prevent HPV and cancer, Gardasil
should never be administered without a prescreening for HPV since
it has the potential to make existing cases worsen.

It is important that people remember that this vaccine will not
eliminate the need for regular PAP screening. No vaccine is 100
percent effective, and Gardasil is designed to protect against only
four strains of HPV.

While Gardasil may be an important medical advance, it is unwise
to compromise the health and safety of the American public, especially
children, by mandating or marketing it before sufficient tests are
concluded.

The
drug could likely go far in replenishing the pockets of the firm as it
recovers from the Vioxx recall, in which Merck’s pain medication was held
to be responsible for 27,000 heart attacks and sudden cardiac deaths.
Analysts estimate that the Vioxx recall decreased Merck’s stock value,
and could cost Merck up to $20 billion in legal settlements.